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Treatment of Cellulite Using the Cellulaze™ Nd:YAG 1440nm Wavelength Laser: Two Case ReportsBarry DiBernardo, MD NewJersey Plastic Surgery, Montclair, NJ

BACKGROUNDCellulite is a topographical alteration to the skin surface in which the skin develops orange peel or mattress-like herniations and depressions within the skin layer. It is a degen-erative condition with an evolutional effect on subcutaneous tissue. It is estimated that cellulite is prominent in 85% of post-adolescent women and manifests itself in areas of the greatest fat accumulation, which include the upper lateral and posterior thighs and the buttocks. Numerous therapies, both non-invasive and invasive, have been suggested, including mesotherapy, energy application (such as a laser or radiofrequency devices), mechanical tissue manipulation, and surgical subcision in the subdermal layer. However, none of these treatments have proven to provide long lasting results for this condition.

Many studies have been undertaken to explain the phys-iopathology of this condition. In summary, the majority of the theories discuss and identify the physical and structural changes to the hypodermis which produce irregular undulations within the skin. The three principal structural changes include flaccidity of the skin; fibrosis of connective tissue in the dermis and subcutaneous tissue; and herniation of subcutaneous fat.

Flaccidity or loose skin is caused by the physiological ptosis of the subcutaneous structures. This results from breaking and destabilizinging the elastic and collagen fibers during the stria formation process, resulting in dermal atrophy. This makes the skin permanently distended and loose, resulting in a less retentive capacity. Ultrasound visualization of herni-ated cellulite reveals a thinning of the dermis and stria, with subcutaneous fat pushing upward, resulting in a herniation of the skin.

Secondly, depressed cutaneous alterations are largely due to fibrosis of the connective tissue in the dermis and subcutaneous tissue. The shortening of these septae due to fibrosis produces retraction, causing the depressions that are characteristic of cellulite.

Thirdly, postpartum women demonstrate an increase in the number or volume of adipocytes in certain predictable locations, including the upper lateral and posterior thighs and the buttocks. This increase in subcutaneous fat leads to the appearance of raised areas as well as augmentation of tension within the lobes, aggravating the depressions.

INTRODUCTIONPreviously published clinical studies1-9 have demonstrated that the effects of delivering thermally controlled laser energy¹ subcutaneously include lysis of the adipocytes membrane1; collagen coagulation of the fibrous septal connective tissue4,8; reorganization of the reticular dermis2,3; and generation of new collagen, resulting in tissue tightening through coagulation² and increased skin elasticity.8, 9

Based on the clinical outcomes described above, a new revolutionary approach was developed and studied for the treatment of cellulite, utilizing a laser to restore the normal structure of the dermal and subcutaneous tissue. This clinical application uses a proprietary SideLaze3D™ (Cynosure, Inc., Westford, MA) delivery system, which provides a targeted and controlled delivery of thermal energy by the laser to specific treatment zones.

The purpose of this study was to evaluate the safety and efficacy of the Cellulaze Nd:YAG 1440nm wavelength laser (Cynosure, Inc. Westford, MA) for a minimally invasive approach to the treatment of cellulite. This approach delivers laser energy subcutaneously within the dermal-hypodermal

interface. The treatment objective is to utilize the clinically published applications and benefits of the laser energy by targeting the three structural deficiencies associated with cellulite. The first step is to apply thermal energy to the herni-ated adipose tissue in order to reduce the raised areas within the subcutaneous tissue. Once complete, the energy is then targeted for thermal subcision of the shortened fibrotic septa, thus releasing the retracted skin and depressions. The third and final step is the delivery of thermal energy to the dermal/hypodermal junction to stimulate dermal remodeling.

ThermaGuide™ (Cynosure, Inc., Westford, MA) subdermal thermal sensing technology is recommended for use in this treatment. ThermaGuide provides the treating physician with the ability to accurately determine treatment doses likely to provide a safer treatment method with more reliable ablation and coagulation of soft tissue, producing tissue tight-ening. Studies have shown the appropriate tissue tempera-ture limits through the correlation of temperature increase to changes in histology.10 The combination of knowledge from these studies with the temperature-sensing ThermaGuide technology easily provides guidance for precise and even energy application. ThermaGuide technology also helps to avoid excessive heating of the skin’s surface and the deeper tissue structures.

Through this precise laser approach, supported by numerous studies, the herniated areas are reduced; areas of depression are released and new connective tissue generated; and the dermis is thickened and remodeled through tissue coagulation.

MATERIALS AND METHODSTwo female subjects with the noticeable appearance of cellulite on the lateral and posterior thighs were enrolled and received one laser treatment in the defined treatment area of the thighs. All subjects agreed to participate in the study and signed an Investigational Review Board (IRB) approved informed consent form prior to the procedure. Treatments were conducted at New Jersey Plastic Surgery by the author, Dr. Barry E. DiBernardo. Subjects were followed for one year. The effectiveness of the treatment was assessed by clinical outcome data, including high resolution photographs, measurements of skin elasticity and skin thickness with high frequency ultrasound, and a post treatment evaluation completed by both patient and physician.

High resolution digital photographs were taken before treat-ment and at one-, three-, six- and twelve-month follow-up visits. Photographs were taken using the same camera, same background and same lighting and exposure conditions to provide maximum skin detail and minimize the potential for bias in evaluating results. 3D images were also obtained before and after treatment using theCanfield Vectra 3D System (Canfield Scientific, Inc., Fairfield, N.J.)

Skin elasticity and skin thickness measurements were taken pre-treatment (baseline), and at one, three, six and twelve months. The skin elasticity was obtained by using a non-inva-sive suction cup probe Cortex Technology DermaLab Suction Cup Probe, (CyberDerm, Media, PA) that was attached to the skin by a light adhesive; a negative pressure will elevate

the volume of skin tissue into the cup. Thus, the modified skin Young’s Module was measured and used as an objective measurement of skin elasticity.

Skin thickness was measured using a high frequency ultrasound imaging system (20 MHz, Cortex Technology DermaScan B, CyberDerm, Media, PA). High frequency ultrasound is defined as the use of high-frequency sound waves to create images of organs and systems within the body. The ultrasound machine uses acoustic frequencies of 20 MHz that reflect off the body structures and a computer uses the reflected waves to create the ultrasound images. The skin thickness is measured and displayed on the ultra-sonic image. Measurements were taken on a consistent basis from the center point of each 5x5 cm square within the treatment area for comparison.

At the one-, three-, six and twelve-month follow-up visits, both physician and subjects completed the post treatment evaluation results on a prepared questionnaire.

Treatment areas were marked with a surgical marker into 5x5 cm squares. Tumescent anesthesia was administered using the Hunstad formula with an average of 50-80cc’s per 5x5 cm area. After the anesthesia, laser energy was delivered using the SideLaze3D fiber for targeted energy, placed through a 1 mm cannula. Laser energy was directed subcutaneously to the marked herniated adipose tissue, depressed fibrotic connective tissue, and then the superficial subdermal area (approximately 0.5 cm below the epidermis) using 6-8 watts of the 1440nm wavelength. Once the laser energy was delivered, the aspirate was removed using a rolled towel by applying pressure to the treated site and drained through the incision site. Patient was then placed in a compression garment and instructed to wear it for the next two to three weeks.

RESULTSThe two treated patients described below showed an average increase in skin thickness compared to baseline of 23% at one month and 27% at one year, demonstrating sustained improvement.

The increase in skin elasticity compared to baseline averaged 32.5% at one month and 21% at one year.

Both physician and subjects rated the post treatment results on a prepared questionnaire which is detailed in each of the following cases outlined below. Overall, the two patients reported minimal side effects at one month, which were all resolved at three months, as well as a high satisfaction rating at one year post-op.

Evaluation of ResultsTreatment efficacy was measured through physician and patient evaluation at one, three, six and twelve months. In addition, digital photography and elasticity and ultrasound measurements were taken at the same intervals.

Evaluation of side effects was based on a 0-3 scale; (0: None; 1: Mild; 2: Moderate; 3: Severe) and improvement scores were based on a 0-4 scale: (0-4 scale refers to: 0: worse; 1: Poor; 2: Fair; 3: Good, 4: Excellent).

Physician EvaluationAll scores at one year indicated that the treatment benefit as perceived by the physician demonstrated continued improve-ment, with good to excellent reduction and improvement, as shown in the table 1 below.

Table 1:

ScoreSwelling

(0-3)Firmness

(0-4)

Reduction of Cellulite

(0-4)

Skin Texture

(0-4)

Overall Improvement

(0-4)

Month 1 0 3 3 3 3

Month 3 0 3 3 4 4

Month 6 2 3 3 3 3

Month 12 0 3 3 4 4

Subject 1 A 48-year-old Hispanic female, 174 pounds, 5’2”, skin type III, BMI 31.9, was enrolled in the study for grade-three cellulite treatment of the posterior thighs, which included both herniation and depressions. Photographs and baseline measurements were taken prior to the procedure via ultrasound, and skin elasticity testing.

A total of six 5×5 cm squares were drawn with a surgical marker covering the treatment area. Areas of herniation greater than 2 cm wide were identified and marked in green, and areas of depression less than 2 cm wide were marked in red, while the patient was in a standing position.

The patient was then given 20 mg of valium and 10 mg of oxycodone as a pre-op sedative with a sip of water. After 10 minutes, standard pre-operative procedures were employed and three entry sites were made using a #2.5 punch biopsy. A total of 530 cc’s of tumescent anesthesia was then administered for an average of 88 cc’s per square.

The laser was set to 6 watts of 1440nm wavelength with a recommended ThermaGuide temperature setting of 45º C to 47º C. The starting temperature reported by the ThermaGuide was 28.7º C. The energy delivery system utilized a unique fiber designed to target laser-generated thermal

energy in a specific direction. Three areas were marked for herniation and treated first with an average of 732 joules per 5x5 cm square area and with the direction of the thermal energy delivered in a down direction to the herniated adipose tissue.

When treatment to adipose tissue was completed, the direc-tion of energy was then changed to lateral, and the fibrotic connective tissue was then thermally subcised. The average amount of energy used for thermal subcision within the 5×5 cm square was 678 joules.

Energy was then directed superficially to the subdermal plane with an average of 855 joules delivered and an average skin surface temperature of 43.6º C, as measured by a handheld infrared thermometer.

When the laser treatment was completed, the aspirate was removed using a rolled towel by applying pressure to the treated site and drained through the incision sites. Incision sites were not sutured to allow for drainage. Standard pressure dressings were then applied to the treated area and the patient was instructed to wear a compression garment for the next two to three weeks.

BASELINE 3 MONTHS 6 MONTHS

Patient EvaluationAll scores at one year indicated that the treatment benefit as perceived by the patient demonstrated continued improve-ment with high patient satisfaction with no side effects. Subject 1 patient evaluation results are listed in Table 2 below.

Table 2:

ScoreDiscomfort

(0-3)Bruising

(0-3)Swelling

(0-3)Numbness

(0-3)Firmness

(0-3)

Reduction of Cellulite

(0-4)

Skin Texture

(0-4)Satisfaction

(0-4)

Month 1 2 3 2 2 1 2 1 1

Month 3 0 0 0 0 2 3 3 3

Month 6 0 0 0 0 2 3 3 3

Month 12 0 0 0 0 2 3 N/A* 3

Skin ElasticitySkin elasticity was measured at one, three, six and twelve months. At one year skin elasticity showed an improvement of 37.25 % from baseline. See image taken below from consistent area for Subject 1.

UltrasoundUltrasound measurements were taken at one, three, six and twelve months. At one year skin thickness showed an average improvement of 45% from baseline. The scaled image in Figure 1 illustrates an increase of dermal thickening at one year for Subject 1.

Digital PhotographyFigure 2 depicts high resolution digital photographs of before and after treatment for Subject 1.

Figure 2: Marked area indicates area of treatment. BASELINE ONE YEAR POST TREATMENT

Figure 1: Subject 1 Ultrasound Photographs

* Missing data point

Subject 2 A 55-year-old Caucasian female, 137 pounds 5’6”, skin type II, BMI 22.1, was enrolled in the study for grade-three cellulite treatment of the lateral thighs, which included linear depressions. Photographs and baseline measurements were taken prior to the procedure via ultrasound and skin elasticity testing.

A total of six 5x5 cm squares were drawn on each leg with a surgical marker covering the treatment area.. Areas of depression greater than 2 cm wide were marked in red while the patient was in a standing position.

The patient was then given 20 mg of valium and 10 mg of oxycodone as a pre-op sedative with a sip of water. After 10 minutes, standard pre-operative procedures were employed and three entry sites were made using a #2.5 punch biopsy. A total of 410 cc’s of tumescent anesthesia was then adminis-tered to each site for an average of 68 cc’s per square.

The laser was set to 8 watts of 1440nm wavelength with a recommended ThermaGuide temperature setting between

at 45º C to 47º C. The starting temperature reported by the ThermaGuide was 26.2º. The energy delivery system utilized a fiber designed to target laser thermal energy in a specific direction. No areas of herniation were noted, and therefore the first area treated was for depressions with an average of 315 joules per 5x5 cm area, with the direction of energy distributing laterally for the thermal subcision of fibrotic connective tissue.

Energy was then directed superficially to the subdermal plane with an average of 948 joules delivered per 5x5 cm square and a skin surface temperature of 43.9º C, as measured by a handheld infrared thermometer.

When the laser treatment was completed, the aspirate was removed using a rolled towel by applying pressure to the treated site and drained through the incision sites. Incision sites were not sutured to allow for drainage. Standard pres-sure dressings were then applied to the treated area and the patient was instructed to wear a compression garment for the next two to three weeks.

Evaluation of ResultsTreatment efficacy was measured through physician and patient evaluation at one, three, six and twelve months. In addition, digital photography and elasticity and ultrasound measurements were taken at the same intervals.

Evaluation of side effects was based on a 0-3 scale; (0: None; 1: Mild; 2: Moderate; 3: Severe) and improvement scores were based on a 0-4 scale: (0: Worse; 1: Poor; 2: Fair; 3: Good; 4: Excellent).

Physician EvaluationAll scores at one year indicated that the treatment benefit as perceived by the physician demonstrated continued improve-ment with good to excellent reduction and improvement as shown in Table 3 below.

Table 3

ScoreSwelling

(0-3)Firmness

(0-4)

Reduction of Cellulite

(0-4)Skin Texture

(0-4)

Overall Improvement

(0-4)

Month 1 1 3 3 4 3

Month 3 0 3 3 4 3

Month 6 0 4 3 4 4

Month 12 0 4 4 4 4

Patient EvaluationAll scores at one year indicated that the treatment benefit as perceived by the patient demonstrated sustained improvement, excellent reduction in cellulite, and high patient satisfaction with no side effects. Subject 2 patient evaluation results are listed in Table 4 below.

Table 4:

ScoreDiscomfort

(0-3)Bruising

(0-3)Swelling

(0-3)Numbness

(0-3)Firmness

(0-3)

Reduction of Cellulite

(0-4)Skin Texture

(0-4)Satisfaction

(0-4)

Month 1 1 1 1 1 2.5 4 3.5 4

Month 3 1 1 1 1 2 3 4 4

Month 6 1 2 0 1 3 4 4 3

Month 12 0 0 0 0 0 4 N/A* 4

Figure 3: Subject 2 Ultrasound Photographs

BASELINE ONE YEAR POST TREATMENT

BEFORE AFTER BEFORE AFTER

* Missing data point

Skin ElasticitySkin elasticity was measured at one, three, six and twelve months. At one year skin elasticity showed an improvement of 37% from baseline.

UltrasoundUltrasound measurements were taken at one, three, six and twelve months. At one year skin thickness showed an average improvement of 15.25% from baseline. The scaled image in Figure 3 illustrates an increase of dermal thickening at one year for Subject 2.

Digital PhotographyFigure 4 depicts high resolution digital 3D photographs of before and after treatment for Subject 2.

Figure 4: Colored areas indicate elevations of depressions in the skin surface. After treatment red colored depressions were reduced to the more even, green color.

ELEVATION

ZERO POINT

DEPRESSION

DiscussionA new minimally invasive laser surgical approach to address the subdermal structural foundation of cellulite has been shown to be a safer, more effective and longer lasting treatment for cellulite as outlined in the two case studies. This approach is based on previously published studies that have demonstrated the clinical benefits of laser energy delivered subcutaneously. This includes the regeneration of collagen within the dermal matrix, laser-assisted surgical subcision and regeneration of connective tissue, and tissue tightening through tissue coagulation.

Follow-up measurements taken at one year suggest a sustained improvement and a high degree of patient satisfaction.

The procedure requires a precise and skilled surgical approach in order to optimize treatment outcomes. This includes the detailed markings of the affected areas and the precise and targeted delivery of thermal energy to the treatment areas. As with all surgical procedures, it is impera-tive to set realistic expectations with each patient.

ConclusionBoth subjects tolerated the procedure well. Recovery symp-toms were mild to none. Mild discomfort, swelling, numbness and bruising were the primary complaints, which resolved in all subjects by three months. Precise and targeted delivery of subcutaneous laser energy to the three principal structural changes within the hypodermis represents a viable option for the treatment and improvement of cellulite.

REFERENCES

1. DiBernardo BE, Reyes J, Chen B, “Evaluation of tissue thermal effects from 1064/1320nm laser-assisted lipolysis and its clinical implications.” Journal of Cosmetic and Laser Therapy 2009, 11:62-69.

2. DiBernardo BE, Reyes J, “Evaluation of skin tightening after laser assisted liposuction.” ASJ 2009, Volume 29, Number 5: 400-407.

3. Goldman A, “Submental Nd:YAG laser-assisted liposuction.” Lasers in Surgery and Medicine 2006, 38:181-184.

4. Goldman A, Gotkin RH, Sarnoff DS, Prati C, Rossato F, “Cellulite: A new treatment approach combining subdermal Nd:YAG laser lipolysis and autologus fat transplantation.” Aesthetic Surgery Journal 2008, Volume 28 Number 6: 656-662.

5. Goldman A, Wollina U, “Subdermal Nd-YAG laser for axillary hyperhidrosis.” Dermatologic Surgery 2008, 34:1-7.

6. Katz B, McBean J, “The new laser liposuction for men.” Dermato-logic Therapy 2007, 20:448-451.

7. Katz B, McBean J, “Laser-assisted lipolysis: A report on complica-tions.” Journal of Cosmetic and Laser Therapy 2008; 10:231-233.

8. Katz B, McBean J, “A pilot study of the efficacy of a 1064 and 1320 sequentially firing Nd:YAG laser device for lipolysis and skin tightening.” Lasers in Surgery and Medicine 2009, 41:779-784.

9. DiBernardo BE, “Randomized, blinded split abdomen study evaluating skin shrinkage and skin tightening in laser-assisted liposuction versus liposuction control” Aesthetic Surgery Journal 2010, 30:593-602.

10. DiBernardo BE, Reyes J, Chen B, “Evaluation of tissue thermal effects from 1064/1320nm laser-assisted lipolysis and its clinical implications.” Journal of Cosmetic and Laser Therapy 2009, 11:62-69.

© 2012 Cynosure, Inc. Cynosure is a registered trademark of Cynosure, Inc. Cellulaze, SideLaze, SideLaze3D and ThermaGuide are trademarks of Cynosure, Inc. 921-0224-000 Rev.3 05/2012

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